The FDA said it “ seized thousands of units of the product,” which contains semaglutide, that was found in the “legitimate U.S. drug supply chain,” according to a news release.
“The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products” that have the lot number NAR0074 and serial number 430834149057, the FDA said. Some of the counterfeit drugs might still be available on the market, it warned.
The advisory said that needles from the drugs also appear to be counterfeit, adding that the “sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products.”
The FDA added that there appears to be at least five “adverse events” connected to the counterfeit lot, although it listed none of them as serious. The reactions are “consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain, and constipation,” the FDA said.
“FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the US,” the FDA release further said.
Ozempic patients and those seeking weight-loss treatment are being advised to only get the drug with a valid prescription through a state-licensed pharmacist or pharmacy.
They’re also advised to check the product to see if there are any signs of the drug being counterfeit, the FDA said, adding that one way to tell is the way in which the pen needle is packaged. An obvious sign of counterfeiting is when the paper tab covering the fake needle says “Novofine®” when it should really say “Novofine® Plus.”
“Entities, including online sellers, selling counterfeit and/or tampered medicines should be reported to FDA. Suspected counterfeit products may be reported to FDA by calling your local FDA consumer complaint coordinator or by reporting it directly at report suspected criminal activity,” the release added.
Demand for Wegovy and Ozempic is exceeding Novo’s supply of the drugs in the United States, Germany, and Britain, leading the company to restrict supplies of certain doses of Wegovy to the U.S. market. Though only Wegovy is approved for obesity, its diabetes counterpart Ozempic also leads to dramatic weight loss, which has led people in the United States and Europe to use the drug “off-label,” meaning not for its approved use.
The FDA said at the time that it has received more than 8,500 reports of gastrointestinal problems in those taking the drugs.
